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Job Description
Looking for a Quality Systems Manager to join an Oncology focused Biotechnology company based in Oxford.
Purpose:
Provide coordination and management in the operation of the Quality Management System (QMS).
- Act as the main point of contact for the business in matters relating to the operation of the QMS.
- To ensure compliance to regulatory requirements, internal polices, Standard Operating Procedures and standards in the operation of the QMS.
- To help ensure continuous improvement of the QMS.
Experience:
At least 2 years’ experience in the operation of quality systems in a pharmaceutical quality related role. Experience of working within sterile pharmaceutical manufacturing and/or radiopharmaceutical manufacturing is desirable but not essential.
Duties:
- Administration and management of the eQMS, document management and learning management systems.
- Development and generation of metrics, measures and reports for the operation of the QMS.
- Oversight and coordination, to ensure the quality and timely management of:
- Change controls / Deviations / CAPAs / Product Quality Reviews / Complaints / Self-inspection
- Quality Risk Register
- Author and implement QMS procedures
- Preparation and management of finished product labelling and patient information leaflets
- Plan and conduct internal audits and self-inspections
- Provide advice and encouragement to staff to ensure individual and company compliance
- Provide training to staff on general or specific quality topics
- Support the QA team in relation to quality investigations and initiatives
- Prepare, manage and present materials for Quality Management Review
- Contribute to continuous improvement activities and take ownership of continuous improvement tasks and projects.
Skills and Competencies:
- Proactive approach and can-do attitude
- Excellent written, verbal and presentation skills
- Excellent organisational skills
- Excellent IT skills for standard desk top packages (experience with Power BI desired but not essential)
- Good analytical skills
- Competent in problem solving, team building, planning and decision making
- Sound knowledge of GMP and/or GCP
Qualifications:
A degree in a science related discipline.
Reporting to:
Associate Director, Quality Operations.
Flexible working available with the requirement to be onsite twice a week.